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Health Affairs Forefront

Sharing The Knowledge: How President Joe Biden Can Use The Defense Production Act To End The Pandemic Worldwide

Doi: 10.1377/forefront.20210804.101816
A person, fully covered in a mask and protective medical gear, is holding a box while several other boxes sit inside the trunk of an SUV.

For months, the Delta variant has devastated countries around the world. Now, it has reached US shores, producing a new wave of illness. The rapid emergence of new coronavirus variants underscores how the spread of the virus around the world poses a threat to national security.

President Joe Biden has recognized our common epidemiological reality. “We know America will never be fully safe until the pandemic that is raging globally is under control. No ocean is wide enough, no wall is high enough to keep us safe.” As he seeks to launch a global wartime effort against the virus, he should also make full use of his authority under the Defense Production Act (DPA) to scale vaccine production globally.

Sharing manufacturing know-how and expertise is critical to quickly ramping up production. But many pharmaceutical corporations have been unwilling to engage in the kinds of sharing that would fully tap into the world’s manufacturing capacity. Offers from manufacturers from Canada to South Korea to help ramp up vaccine production have been rebuffed or ignored. The South Korean government, for example, has said it can offer the capacity to produce one billion mRNA vaccine doses immediately, but failed so far to secure mRNA technology from a willing pharmaceutical corporation. According to the World Health Organization, 19 manufacturers from more than a dozen countries in Africa, Asia, and Latin America have expressed interest in ramping up mRNA vaccine production. Neither Moderna nor Pfizer-BioNTech have been willing to support these efforts fully, despite direct appeals from global health leaders. The Biden administration has also urged companies to share technology.

Expanding the world’s manufacturing capacity is critical because donations and bilateral agreements to increase vaccine doses in low- and middle-income countries cannot quickly meet the global demand. Approximately 11 billion doses are needed to vaccinate the world’s population, but to date, the US government has donated just 40 million doses. More recent promises by the G7, including the US announcement to donate Pfizer doses, would only deliver an additional one billion doses by the end of 2022.

President Biden can help the world benefit from vaccine technology and work to secure the US against future variants, by using the DPA. In the name of national defense, the president can use his authority to require pharmaceutical corporations to accept technology transfer contracts and to allocate scarce manufacturing know-how in exchange for reasonable compensation. Combined with a surge investment, President Biden can use the DPA to quickly set up regional hubs capable of pumping out billions of doses. He can save millions of lives, trillions of dollars, and protect Americans from the risk of emerging viral threats.

Sharing The Vaccine Recipe

Technology transfer refers to “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites.” In the context of vaccine manufacturing, the aim of technology transfer is to equip a receiving site with the knowledge needed to produce doses. Third-party manufacturers may be able to produce vaccines independently if they have freedom from intellectual property barriers. But sharing know-how can help expand capacity in the short term. Based on how technology has been transferred so far during the pandemic, we can draw three general lessons:

First, technology transfer can happen quickly. According to data compiled by Knowledge Ecology International, manufacturers of COVID-19 vaccines typically started production within six months after technology transfer began. For example, BioNTech bought a cancer antibody factory in September 2020 and was able to train staff, receive regulatory authorizations, and start commercial mRNA vaccine production by March 2021.

Second, technology transfer can occur with relatively limited resources. Novavax conducted multiple technology transfers, with a team of around a dozen people flying around the world. AstraZeneca was able to transfer technology to an Argentinian partner virtually, sharing expertise exclusively through Zoom video calls and webinars.

Third, although companies have initiated limited technology transfer on their own, it has been insufficient. Manufacturers around the world have noted they can help ramp up production if they have access to technology. But vaccine originator corporations have been reluctant to share technology. And, in cases where they have shared technology, the resulting partnerships have been restrictive and narrow in scope. Novavax, for example, initially allowed the Serum Institute of India to only fill and finish vials, instead of producing the antigen itself. 

This failure stems in part from commercial concerns: Pharmaceutical corporations are unwilling to provide expertise to firms they perceive as competitors. This is particularly salient for holders of technologies such as mRNA, which could prove useful for more lucrative disease areas in the future. It may be profit-maximizing for a corporation to restrict access to a technology and forgo royalties for a coronavirus vaccine if it could garner a larger share of the market for a more lucrative disease. Under the existing industry-led approach, the speculative future private value outweighs the enormous present public benefit of sharing technology.

Unleashing the full potential of global COVID-19 vaccine manufacturing thus requires government intervention. Shortages of non-monopolized materials such as glass vials are an issue, but a transient one because they can be addressed in conventional ways. To overcome monopoly, however, we need both action on intellectual property (including the TRIPS waiver) and concerted action to mandate sharing of information and data. The US government, as the largest coronavirus research and development funder in the world, is uniquely positioned to push companies to share the knowledge required to end the pandemic.

Legal Authority To Mandate Technology Transfer

Based on the War Powers Acts of World War II, the Defense Production Act provides the president with broad authority to support the nation’s defense. Recognizing that security needs reach far beyond wartime settings, Congress has repeatedly amended the definition of “national defense” over time. Currently, its definition includes “military or critical infrastructure assistance to any foreign nation,” and “critical infrastructure assistance and protection” (which includes systems and assets, the degradation of which would have a debilitating impact on “national public health”), as well as “emergency preparedness activities.”

Scaling up global vaccine production capacity fits squarely within the act’s definition of national defense needs. Global vaccine capacity is critical infrastructure needed to scale-up vaccine supply, end the pandemic, and keep Americans safe. More than 600,000 Americans have already died from COVID-19. The continued replication of SARS-CoV-2 abroad increases the likelihood of a harmful mutation that renders current vaccines ineffective, which could plunge the country back into crisis and take more US lives. Even if a variant does not escape the vaccines, a new variant could be more transmissible and cause more severe disease, posing a higher risk to the millions of Americans who have not been vaccinated. The Delta variant, for example, poses this threat. Programs to achieve global vaccination would also constitute an activity to prepare for and minimize the threat that a new variant poses to the US population, thereby establishing it as an “emergency preparedness activity.”

Under the plain text of the DPA, the president can mandate the sharing of know-how from US-based pharmaceutical companies to support the national defense need of global vaccination. We focus on two authorities granted by the act in particular but have outlined others elsewhere.

First, Title I of the DPA empowers the president to directly “allocate materials, services, and facilities” to promote national defense needs. The act defines “materials” to include not only more tangible objects, such as “commodities,” “products,” and “articles” but also “any technical information or services ancillary to the use of any such materials.” Information about the vaccine production process is exactly the kind of technical information that the act explicitly includes within its definition of materials that can be allocated by the president for national defense purposes.

Second, Title I of the DPA, executive order 13603, and implementing regulations make clear that the federal government can require companies to accept and prioritize contracts that promote national defense. The US clearly has the ability to contract with these companies to transfer their technology to scale up vaccine production. For example, as part of its contract with the US government, Pfizer agreed to transfer the know-how and production process from its partner BioNTech in Europe to the US. The DPA establishes that the president can go a step further and require the acceptance and prioritization of these contracts by US pharmaceutical companies to advance national defense needs.

Drawing on the DPA, the US government could establish a "technology hub.” The federal government can clearly wield the act to mandate sharing of know-how about producing COVID-19 vaccines with a US governmental entity, such as the Biomedical Advanced Research and Development Authority (BARDA). BARDA, in turn, could share this critical information with the world under the government’s authority independent of the DPA to increase global COVID-19 vaccine production. For example, BARDA could draw on its expertise running a successful program to accelerate the local production of influenza vaccines across the globe by aiding the construction of manufacturing facilities abroad and the training of personnel from foreign nations.

The US government could also directly require companies to share technology abroad, entering into new partnerships with foreign manufacturers and the World Health Organization. Although the DPA statute appears to limit the law’s application to the US and its territories, it can still be used within the United States to effectuate technology transfer abroad for at least two reasons. First, historical practice supports such uses of the DPA. The law has been used repeatedly since at least 2003 to prioritize contracts and orders from US companies to foreign nations. Notably, the Biden administration likely used the DPA to redirect vaccine raw materials from AstraZeneca in the US to the Serum Institute in India. Second, the DPA itself has been explicitly modified to include various foreign uses. The territorial limitation was passed as part of the act in 1950. In 2009, however, Congress amended the definition of “national defense” under the DPA to include “military or critical infrastructure assistance to any foreign nation.” This demonstrates that Congress clearly envisioned uses of the DPA within the United States that assist the critical infrastructure of foreign nations. Requiring US-based pharmaceutical companies to transfer their know-how to foreign nations and manufacturers clearly supports the critical infrastructure needs of foreign nations.

In any case, the federal government should reasonably compensate US companies for transferring know-how to scale up global vaccine production, taking into account the risk-adjusted value of federal subsidies, investments, and technology. In the case of Moderna, for example, the company was paid nearly a billion dollars by the government to run vaccine clinical development and learn how to scale its manufacturing process. Moderna also does not have permission to use a key patented government technology incorporated in the vaccine, which scholars estimate could allow the government to demand more than a billion dollars in compensation from Moderna based on its 2021 US sales projections alone.

Legal challenges are possible, but it is unlikely they would succeed. For example, the takings clause of the Fifth Amendment prohibits the government from taking private property for public use, without just compensation. Although it is not clear whether sharing technology would trigger the takings clause, even if it did, courts cannot block the sharing (that is, issue an injunction) so long as it occurs for a public use and just compensation is provided. Sharing know-how to end a pandemic would clearly be for public use and thus permitted, and ensuring a fair royalty would satisfy the “just compensation” requirement. Indeed, the US Supreme Court has long held that “as long as just compensation remedies are available...injunctive relief will be foreclosed.”

Global Cooperation

The Biden administration has said it wants to bring a wartime response to the global vaccine effort. The Defense Production Act offers a powerful set of tools to share technology and ramp up global vaccine production. Sharing the knowledge that can end a pandemic is not just the right thing to do. It is also the best way to protect Americans.

The transmission of SARS-CoV-2 abroad will continue to ravage countries with limited means to address the virus. It also magnifies the risk of new, more dangerous variants that can potentially escape our vaccines. The threat of new variants poses a risk to the lives of millions globally. Already, more Americans have died from COVID-19 than from World War I, World War II, the Vietnam War, and 9/11 combined. President Biden has recognized this staggering toll.

But this pandemic will not end without far deeper global cooperation. By supporting technology transfer abroad and the creation of regional hubs to produce sufficient vaccine doses for the globe, the United States can not only help bring this global tragedy to a close but also establish the necessary infrastructure to deal with future pandemics. In this way, the Biden administration can help end this pandemic—and potentially all others.